ENCePP Guide on Methodological Standards in Pharmacoepidemiology

4.5. Social media and electronic devices

Technological advances have
dramatically increased the range of data sources that can be used to complement
traditional ones and provide compelling insights into effectiveness and safety
of interventions. Such data include digital social media that exist in a
computer-readable format on websites, web pages, blogs, vlogs, social networking
sites, internet forums, chat rooms, health portals, etc. A recent addition to
this list is represented by the data collected through mobile and other device
applications such as wearable technology.

There is a growing interest to
use these data sources to generate patient-generated information relevant for
medicines safety surveillance.

Social media is a source of
potential reports of suspected ADRs. Marketing authorisation holders (MAHs) are
legally obliged to screen web sites under their management and assess whether
they qualify for reporting Spontaneous ADRs identified from social media should
be handled as unsolicited reports and evaluated and reported in a similar way.

Another use of social media might
be for identification of new safety issues (signal detection). It would have
added value only if more issues would be identified or it would help faster
identification, but there is currently no evidence this is the case. Using Social Media Data in Routine Pharmacovigilance: A Pilot
Study to Identify Safety Signals and Patient Perspectives (Pharm Med (2017) 31: 167-174) explores whether
analysis of social media data could identify new signals, known signals from
routine pharmacovigilance, known signals sooner, and specific issues
(i.e., quality issues and patient perspectives). Also of interest in
this study was to determine the quantity of ‘posts with resemblance to AEs’
(proto-AEs) and the types and characteristics of products that would benefit
from social media analysis. It concludes that
social media data analysis cannot identify new safety signals but can provide
unique insight into the patient perspective. Assessment was limited by numerous
factors, such as data acquisition, language, and demographics. Further research
is deemed necessary to determine the best uses of social media data to augment
traditional pharmacovigilance surveillance.

There is one ongoing EU project
investigating the potential for publicly available social media data for
identifying drug safety issues (WEB-RADR). The results of the WEB-RADR project will inform
regulatory policy on the use of social media for pharmacovigilance, initial
results show there may be utility for specific niche areas such as misuse/abuse
or off-label use.

There is currently no defined
strategy or framework in place in order to meet the standards around data
validity, generalisability for this type of data. Therefore regulatory
acceptance of this type of data might be lower than for traditional sources.

Before an informed strategy is
put in place, the following factors may be considered when using social media
and electronic data sources and devices using social media:

Completeness of data capture.

Validation processes defined for the devices, including accuracy

Reliability and reproducibility of outputs/inputs from the device

Data warehousing requirements for secure storage of the volume of data
potentially received from wearable devices.

Data from social media and
electronic devices can be both structured and unstructured. When analysing
unstructured data, the following factors may be considered:

Tools used for crawling the web and the methods used for handling
unstructured data should be well defined along with their potential limitations
e.g. the type of natural language processing (NLP) approach and software
used.

How exposure and outcomes were defined within unstructured data and whether
these have been derived and validated.